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NCT04826523Completed

Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants Above 19 Years of Age With Acute Myeloid Leukemia (AML)

Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for AML Patients

Source: ClinicalTrials.gov · Last updated 26 Nov 2025

Brief summary (registry, in English)

Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective oral venetoclax is in participants with AML . Adverse events and change in disease activity will be monitored under routine clinical practice. Venetoclax is an approved drug for treatment of Acute Myeloid Leukemia (AML). Around 600 participants of age 19 years and above will be enrolled in the study in multiple medical institutions across South Korea. Participants will receive oral venetoclax tablets as prescribed by their physician in the routine clinical practice. Participants will be observed for 7 cycles ( each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Status (registry)
Completed
Study type
Observational
Enrollment
150 (actual)
First submitted
31 Mar 2021
Start date
5 Apr 2021
Primary completion date
20 Oct 2025
Lead sponsor
AbbVie
NCT number
NCT04826523

What you commit to

  • Study type: Observational
  • Participants enrolled: 150
  • From 5 Apr 2021 to the primary completion date, 20 Oct 2025
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants receiving Venetoclax in clinical trials.

Other

  • Participants with contraindications to Venetoclax as listed on the approved local label.

Who the study is looking for

  • --Acute Myeloid Leukemia (AML) participants who have been prescribed oral Venetoclax tablets for the first time according to the approved label.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kosin University Gospel Hospital /ID# 257399
Coordinator of this site? Confirm its status
BusanSouth KoreaUnknown status
Pusan National University Hospital /ID# 239010
Coordinator of this site? Confirm its status
BusanSouth KoreaUnknown status
Kyungpook National University Hospital /ID# 257398
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
Yeungnam University Medical Center /ID# 239007
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
Chonnam National University Hwasun Hospital /ID# 257478
Coordinator of this site? Confirm its status
Hwasun-gunSouth KoreaUnknown status
Gachon University Gil Medical Center /ID# 239008
Coordinator of this site? Confirm its status
IncheonSouth KoreaUnknown status
Yonsei University Health System Severance Hospital /ID# 239006
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Seoul National University Hospital /ID# 257477
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SeoulSouth KoreaUnknown status
Samsung Medical Center /ID# 239009
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Korea University Anam Hospital /ID# 231022
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.